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Showing 1121–1140 of 1571 results

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Diclofenac Sodium Solution (Preferred) - Container Defect (2021)

Defective container: Out of specification for container integrity leading to bottles leaking.

Class IIModerate

FDANov 29, 2021CT, FL, IN +1 more• Preferred Pharmaceuticals, Inc.

Butalbital APAP Caf Tablets (Bryant Ranch) – Incomplete Labeling (2021)

Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label

FDASep 28, 2021Nationwide• Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Chantix 0.5mg/1mg Tablets (Pfizer) – Impurity Risk (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Class IIModerate

FDAAug 13, 2021Nationwide• Pfizer Inc.

Chantix 1mg Tablets (Pfizer) – Impurity Risk (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Class IIModerate

FDAAug 13, 2021Nationwide• Pfizer Inc.

Chantix (Pfizer) – Impurity Risk (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Class IIModerate

FDAAug 13, 2021Nationwide• Pfizer Inc.

Chantix (Pfizer) – Impurity Risk (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Class IIModerate

FDAAug 13, 2021Nationwide• Pfizer Inc.

Lidocaine Topical Solution (Teligent) – Potency Problem (2021)

Superpotent Drug

FDAAug 3, 2021Nationwide• Teligent Pharma, Inc.

Combipatch 0.05/0.25mg (Noven) – Stability Failure (2021)

Failed Stability Specifications; out of specification for shear.

Class IIModerate

FDAJul 30, 2021Nationwide• Noven Pharmaceuticals Inc

Combipatch 0.05/0.14mg (Noven) – Stability Failure (2021)

Failed Stability Specifications; out of specification for shear.

Class IIModerate

FDAJul 30, 2021Nationwide• Noven Pharmaceuticals Inc

Erythromycin Topical Solution (Teligent) – Container Defect (2021)

Defective container: possibility for lack of seal integrity.

Class IIModerate

FDAJul 29, 2021Nationwide• Teligent Pharma, Inc.

Miss Slim Capsules (HIS Enterprise) – Unapproved Marketing (2021)

Marketed without ANDA/NDA approval

Class IIModerate

FDAJul 20, 2021Nationwide• HIS ENTERPRISE INC

Chantix (Pfizer) - N-nitroso-varenicline impurity (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit

Class IIModerate

FDAJun 9, 2021Nationwide• Pfizer Inc.

Chantix (Pfizer) - N-nitroso-varenicline impurity (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit

Class IIModerate

FDAJun 9, 2021Nationwide• Pfizer Inc.

Chantix (Pfizer) - N-nitroso-varenicline impurity (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Class IIModerate

FDAJun 9, 2021Nationwide• Pfizer Inc.

Daytrana 10mg (Noven) - Patch Defect (2021)

Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.

Class IIModerate

FDAMay 20, 2021Nationwide• Noven Pharmaceuticals Inc

Daytrana 15mg (Noven) - Patch Defect (2021)

Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.

Class IIModerate

FDAMay 20, 2021Nationwide• Noven Pharmaceuticals Inc

Vitaccino Coffee (DASH XCLUSIVE) – Undeclared Ingredients (2021)

Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine

Class IIModerate

FDAMay 11, 2021Nationwide• DASH XCLUSIVE

Metformin HCl Extended Release (Preferred) – NDMA Impurity (2021)

CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.

Class IIModerate

FDAApr 28, 2021FL, IN• Preferred Pharmaceuticals, Inc.

Cephalexin Oral Suspension (Preferred) – impurity issue (2021)

Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test analysis of Cephalexin

Class IIModerate

FDAApr 12, 2021CA• Preferred Pharmaceuticals, Inc.

Flurandrenolide Ointment (Teligent) – specification failure (2021)

Failed Impurities/Degradation Specifications:

Class IIModerate

FDAApr 9, 2021Nationwide• Teligent Pharma, Inc.

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